Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

FAT · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

163 daysmedian FDA review time

263 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K133439	PILLING ESOPHAGEAL BOUGIES	Teleflexmedical, Inc.	2014-06-16	216	0
K983220	STRYKER INFRAVISION ESOPHAGEAL KIT	Stryker Endoscopy	1999-06-04	263	2
K972119	MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)	Medovations, Inc.	1998-02-02	242	0
K960173	INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT	Gabriel Medical, Inc.	1996-06-27	163	0
K901425	PYLORIC BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87	0
K843186	ESKA MULTISTAGE ESOPHAGEAL BOUGIE	Dacomed Corp.	1985-01-18	158	0
K842679	ESOPHAGEAL DILATOR SET	Mill-Rose Laboratory	1984-10-02	84	0
K780471	GASTRIC LAVAGE KIT	Gaymar Industries, Inc.	1978-06-02	70	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda